Suturing instrument and method for passing multiple sutures

ABSTRACT

Apparatus and methods for passing multiple sutures in tissue repair and/or other mini-open procedures. The apparatus includes a pair of jaws mounted on a distal end of a shaft, a hand assembly mounted on a proximal end of the shaft, and a needle mounted on the hand assembly and passing through a cannulation of the shaft. The pair of jaws includes a lower jaw and an upper jaw, the lower jaw being provided with a slot configured to sequentially engage multiple sutures inserted into the instrument. The handle assembly has a cam mechanism and a finger lever with a ratchet and a releaser with a hook, the handle assembly being designed to move the needle from a first position to a second position, and to thereby sequentially capture, in the needle, each of the multiple sutures inserted in the instrument, for subsequent passing through tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/112,533, filed Nov. 7, 2008, the entire disclosure of which isincorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates to the field of surgery and, moreparticularly, to a suture passing instrument configured to pass multiplesutures independently through tissue.

BACKGROUND OF THE INVENTION

Both open and endoscopic surgical procedures often require sutures toligate, join or otherwise treat tissue. Generally, suture needles withattached suture strands are grasped either manually or by forceps andpassed through the desired work site so a knot can be tied. While theprocedures are fairly uncomplicated in open surgery where most suturesites are readily accessible, in endoscopic procedures, where access tothe work site is not readily available, the surgeon must use auxiliarydevices to be able to grasp the suture strands and pass them throughdesired tissue.

Although various instruments and techniques have been developed forsurgical repairs requiring the passing of sutures to distant locations,instruments that allow a surgeon to quickly, accurately, and easily passmultiple sutures through soft tissue are still needed.

SUMMARY OF THE INVENTION

The present invention provides a suture passing instrument and surgicaltechnique for surgical repairs. The suture passing instrument comprisesan elongated tubular member and a tip configured to be loaded with aplurality of flexible strands (such as sutures, for example) that arepassed independently and without the need to pull the instrument out ofthe surgical site to reload the sutures.

Other features and advantages of the present invention will becomeapparent from the following description of the invention which refers tothe accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a top view of a lower jaw of a suture passinginstrument of the present invention, with a first flexible strandpositioned thereon and adjacent a needle.

FIG. 2 illustrates a top view of the lower jaw of the suture passinginstrument of FIG. 1, with the needle advanced and the first flexiblestrand shifted into the slot of the needle.

FIG. 2( a) illustrates a view of a proximal end of the suture passinginstrument of FIG. 1, with the thumb pad down to advance the needleuntil the first flexible strand shifts into the slot of the needle.

FIG. 3 illustrates a top view of the lower jaw of the suture passinginstrument of FIG. 1, with a second flexible strand positioned thereon.

FIG. 4 illustrates a top view of the lower jaw of the suture passinginstrument of FIG. 1, with the first flexible strand advanced by theneedle and positioned distal to the second flexible strand.

FIG. 4( a) illustrates a view of a distal end of the suture passinginstrument of FIG. 1, with the first and second flexible strands pulledback by hand.

FIGS. 5-13 illustrate various views of the suture passing instrument ofFIG. 1, and at different stages of loading two flexible strands on thelower jaw of the instrument.

FIGS. 14( a)-(e) and 15 illustrate exemplary suturing steps during anarthroscopic rotator cuff repair and employing the suture passinginstrument of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a suture passing instrument and techniquefor surgical repairs. The suture passing instrument comprises anelongated tubular member and a tip configured to be loaded with aplurality of flexible strands (such as sutures) that are passedindependently and without the need to pull the instrument out of thesurgical site to reload the sutures. The sutures are loaded onto theinstrument outside of the surgical site, and then are independentlypassed inside the surgical site (without the need to pull the instrumentout of the surgical site to reload the sutures). A bendable needlepasses the sutures from the instrument through the tissue at thesurgical site.

The suture passing instrument generally comprises an elongated tubularmember with a handle assembly located at the proximal end and a tiplocated at the distal end. The tip comprises a fixed lower jaw and anupper movable jaw. The handle assembly provides for opening and closingof the upper jaw coupled to the tip of the instrument. A ratchetingmechanism provides for locking and unlocking of the jaw as desired bythe user. Additionally, the handle assembly houses a mechanism foradvancing and retracting the needle.

A first suture is loaded into a slot of the lower jaw of the instrument.By actuating a spring loaded thumb pad, a needle is pushed forward toallow the first suture to shift into the slot of the needle. Uponrelease of the thumb pad, the needle is retracted to the originalposition, and a second suture is loaded onto the slot of the lower jawof the instrument. The handle assembly of the instrument is squeezed toadvance the needle, so that the first suture is now distal the secondsuture. The instrument is now loaded. The jaws are opened to grasptissue and closed to hold tissue using the finger lever and ratchetingmechanism. Once the instrument is in position, the first suture ispassed through tissue by squeezing the handle assembly together. Theneedle is then retracted (for example, fully retracted) by releasingpressure on the handles; the jaws are opened to move the instrument toan adjacent region of the tissue and closed again. Squeezing the firstand second handles again captures and advances the second suture throughan adjacent region of tissue.

Referring now to the drawings, where like elements are designated bylike reference numerals, FIGS. 1-15 illustrate various structuralelements of suture passing instrument 100 of the present inventionprovided with a jaw configured to allow at least two flexible strands tobe loaded thereon and a handle assembly allowing the two strands to bepassed independently (and without the need to remove the instrument fromthe surgical site to reload it with an additional strand).

As shown in FIGS. 5-13, suture passing instrument 100 comprises anelongated tubular member or shaft 12 having a longitudinal axis, aproximal end 11, a distal end 13 and an axial throughbore therein (notshown). Shaft 12 may be a tube or a narrow-diameter rod of dimensionsthat permit the tubular member to be introduced through an associatedcannula (for example, an 8.25 cannula) in a minimally invasiveprocedure, such as arthroscopic or other endoscopic procedures, or intoa body cavity, such as the abdominal cavity. Alternatively, shaft 12 maybe an open U channel (and not a closed tube).

Elongated tubular member 12 extends between a handle assembly 20 and atip 10 consisting of a pair of jaws comprising an upper jaw 10 a and alower jaw 10 b. Lower jaw 10 b is provided at the distal end 13 of theinstrument and is preferably integral with the tubular member 12. Upperjaw 10 a forms part of the tip 10 and may pivot with respect to the tipor lower jaw 10 b. As illustrated in FIGS. 5-13, lower jaw 10 b issubstantially straight with respect to the shaft, while the upper jaw 10a is either straight or curved, and may be provided with a plurality ofteeth to enhance tissue grasping and suture passing stability. In anexemplary embodiment, the upper jaw 10 a is curve-shaped, preferablyhump-back shaped, having a certain radius of curvature and is pivotallyconnected to the lower jaw 10 b. The upper jaw 10 a is designed toaccommodate tissue to be grasped between the upper and the lower jaws,10 a, 10 b.

The bottom jaw 10 b of the instrument is illustrated in more detail inFIGS. 1-4. The bottom jaw 10 b includes a longitudinal channel 16 and asecuring mechanism 17 provided at the distal end of the lower jaw 10 b.In exemplary embodiments, the securing mechanism 17 may be a sutureloading slot 17 in communication with the longitudinal channel 16. Thelongitudinal channel and the securing mechanism (loading slot) areconfigured to allow at least one suture (or at least a strand offlexible material) to extend therethrough and to be securely positionedwithin the securing mechanism (loading slot). Slot 17 may have variousconfigurations, for example, a groove (such as a V groove) or a wedge,to allow multiple suture positioning for future suture manipulation withthe construct of the invention. The securing mechanism 17 is formedintegrally with the lower jaw 10 b.

Lower jaw 10 b is configured to allow loading of sutures (for example, afirst suture 80 a and a second suture 80 b) onto the securing mechanism17 (loading slot) and then on the needle 55 for advancement throughtissue. As shown in FIGS. 1 and 2, suture 80 a is loaded through thelongitudinal channel and into slot 17 so that a first end of suture 80 ais held beneath the lower jaw 10 b and the other end of the suture 80 ais held above the lower jaw 10 b. The ends of suture 80 a may be pulledin a proximal direction and to the left side (FIG. 1) for furtherengagement by needle 55. When needle 55 is actuated and advanced towardsthe distal end of the lower jaw 10 b (by actuating actuator 50, asdetailed below), the suture 80 a shifts into slot 66 of the needle 55.Once suture 80 a has been secured within slot 66 of the needle 55 (andpreferably before advancement of the suture 80 a by the needle), asecond suture 80 b may be loaded onto the instrument (as shown in FIG.3, and as explained in more detail below). The first suture 80 a ispassed through the tissue to be sutured, by squeezing the handlestogether and then releasing the pressure on the handles to allow theneedle to return to its original position within the longitudinalchannel of the lower jaw 10 b. The handles are again squeezed togetherand the second suture 80 b is shifted from the securing mechanism(loading slot) 17 and onto the slot 66 of the needle 55 for furtherengagement and advancing of the suture 80 b through tissue.

The suture 80 a, 80 b is preferably a braided high strength suture suchas a Fiberwire™, sold by Arthrex, Inc., Naples, Fla. (for example, a #2Fiberwire).

The handle assembly includes a first handle, a second handle, a fingerlever, a ratchet-like mechanism, and a cam mechanism between the firstand second handles. The ratchet-like mechanism is pivotally connected tothe handle and the finger lever. The finger lever articulates a jaw(coupled to the tip of the elongated tubular member) relative to theelongated tubular member with the ratcheting mechanism locking andunlocking the jaw in an open or closed position.

Channel 16 of the lower jaw 10 b is configured to allow needle 55(preferably, a bendable needle 55) to extend through a portion of thechannel 16 and exit through opening 5, as illustrated in FIGS. 2 and 4.Needle 55 is substantially disposed within a cannulation 12 a passingthrough the shaft 12. The proximal end of the needle 55 has thumbpad/pusher 54 having a cross pin 51 for engagement with slot 53 providedon the proximal end of the handle. Pushing on the thumb pad 54 moves thecross pin 51 along the slot 53 causing the distal end of the needle 55to advance into the channel 16 of the lower jaw 10 b. When the thumb padis fully depressed, the slot 66 of the needle 55 is in alignment withthe loading slot 17 of the lower jaw 10 b. Additionally, the needle 55may be moved between various positions along the longitudinal channel 16by moving the proximal and distal ends 29 a, 29 b of the handle 20closer to each other.

The lower jaw 10 b is configured to house a portion of the needle 55.Needle 55 is substantially disposed within a channel 16 a within thelower jaw 10 b when the needle is in a non-operative, or non-piercing,position. In an operative position, the needle is advanced distally toexit opening 15 in the lower jaw 10 b. The needle 55 is bendable so thatit can be moved generally with an axial force and can be bent on acurve, for example, 90 degree to move generally toward the upper jaw 10a. Needle 55 can be bent at any angle and advanced in any direction.

Needle 55 has a pointed tip 60 at a most distal end of the needle and aslot or hook 66 provided in the distal end and preferably on a lateralside of the needle. The pointed tip 60 is designed to pierce the tissueand the slot 66 is designed to capture and carry the suture. Preferably,the needle has a generally flat, narrow and elongate configuration.Needle 55 may preferably be formed of nitinol or other suitablematerial.

Handle assembly 20 of the suturing instrument 100 illustrated in FIGS.5-12 is provided at the proximal end 11 of the instrument and includes aratchet-like mechanism 22 and a handle 28 with ends 29 a, 29 b, theratchet-like mechanism 22 being pivotally connected to the handle 28.The ratchet-like mechanism 22 consists of a finger lever 22 a withratchet arms 25 a, 25 b, and a releaser 23, the ratchet arms 25 a, 25 bhaving a plurality of teeth to engage each other. The finger lever 22 aand the ratchet arms perform substantially similar to a ratchet and apawl. The finger lever 22 a is pivotally connected by pivot pin 21 tothe distal end 29 b of the handle. The releaser 23 locks and unlocks theratchet arms 25 a, 25 b.

The finger lever 22 a is designed to move from a first position to asecond position, corresponding to opening and closing the upper jaw 10a. A spring 27 is provided to maintain tension on the finger lever 22 aand to force the finger lever 22 a to go back to a default position,i.e., the open position. At its default position, the finger lever 22 ais farthest from the distal end 29 b of the handle 28. The suturepassing instrument 100 further includes an actuator which is providedwithin the shaft 12 and at the distal end of the shaft. A proximal endof the actuator is pivotally connected to the finger lever 22 a and adistal end of the actuator is pivotally connected to the upper jaw 10 a.The actuator is designed to move the upper jaw 10 a from a firstposition to a second position as the finger lever 22 a is moved from afirst position to a second position. At the default position of thefinger lever 22 a, the upper jaw 10 a is farthest from the lower jaw 10b. The releaser 23 is designed to move from a first position to a secondposition, corresponding to locking the ratchet arms together orunlocking the ratchet arms.

The proximal and distal ends 29 a, 29 b of the handle 28 are connectedvia a link 28 a and tension between the proximal and distal ends may beadditionally maintained using spring 28 b. The link 28 a includes a cam30 and opening 32. Opening 32 includes a first end 32 a and a second end32 b. First end 32 a has a smaller width than the second end 32 b. Whencam 30 is positioned within first end 32 a, the cam is in a neutralposition, and the handles are a maximum distance apart from each other.As the cam 30 moves along opening 32 towards the second opening, thehandles 29 a, 29 b move towards each other and the cam locks them in aforward position which forces the needle to advance along thelongitudinal channel 16. When the handles are squeezed together and thecam is in the second opening, the cam compresses, traveling to the endof the opening 32 and allows the handles to fully release. This movesthe needle 55 through the entire longitudinal channel 16 and out theexit opening 15 and returns it back into the shaft 12 of the instrument.As the needle moves through the channel it captures the suture andpasses it through the tissue. With handle assembly 20, a surgeon mayseize and grasp tissue with jaws 10 a, 10 b. As detailed below, usingpusher 54, the needle is advanced to capture the first suture strandpositioned within slot 17, and to further carry and advance the capturedfirst suture strand through the tissue to be sutured. Subsequently, theneedle is retracted and advanced to capture the second suture strand andto further advance the captured second suture strand through anotherregion of the tissue.

An exemplary method of employing the suture passing instrument 100 ofthe present invention begins by loading the needle 55 into thecannulation on the proximal end of the shaft 12 of the suture passinginstrument 100, and also two flexible strands 80 a, 80 b (for example,two flexible suture strands 80 a, 80 b) onto the bottom jaw of theinstrument. The slot on the proximal end of the actuator 50 is engagedsecurely into a cross pin on the proximal end of handle 28 of the suturepassing instrument (FIG. 2( a)).

In an exemplary and illustrative embodiment only, about 1-2 inches of afirst flexible strand 80 a (for example, a #2 FiberWire) is loaded intothe slot on the bottom jaw 10 b (FIGS. 1 and 2). Both leads of the firstsuture 80 a (FiberWire) are grabbed and pulled back to the left side.The other hand may be placed on the back end of the instrument 100, withthe thumb on top of the thumb pad.

The thumb pad 54 of actuator 50 is pushed down to advance the needle 55until the first suture 80 a shifts into the slot 66 of the needle 55.The needle 55 will retract to its original position as the downwardpressure from the thumb is released.

In an exemplary and illustrative embodiment only, about 1-2 inches of asecond flexible strand 80 b (for example, a #2 FiberWire or a stranddifferent from the first suture strand) is loaded into the slot (FIGS. 3and 4). The four leads of the first and second strands are grabbed andpulled back with the first loaded suture strands on the left, and thesecond loaded strands on the right (see FIG. 4( a)). The other hand maybe placed on the back end of the instrument, avoiding the front lever.

FIGS. 7-11 illustrate additional views of the suture passing instrument100 showing in more detail the cam function during the loading anddelivering of the first and second suture strands 80 a, 80 b. Theloading of the first suture 80 a begins by positioning the suture 80 awithin the slot 17 (FIG. 7 a) and pulling the first suture 80 a to theleft (down in the top view of FIG. 7 a). As shown in FIG. 7( a), theneedle 55 remains in retracted neutral position and, as shown in FIG. 7(b), the cam 30 also remains in neutral position (with the black button,the thumb pad 54, also remaining in neutral position). The black button(the thumb pad 54) is then pushed down (to advance the needle 55) andreleased (FIG. 8). As shown in FIG. 8( a), the needle 55 is slightlyadvanced to capture the first suture strand 80 a and, as shown in FIG.8( b), the cam 30 remains in neutral position (with the black button,the thumb pad 54, also remaining in neutral position).

The loading of the second suture 80 b begins by positioning the secondsuture 80 b within the slot 17 and pulling the second suture 80 b (notshown) to the right (up in the top view of FIG. 9 a). As shown in FIG.9( a), the needle remains in retracted neutral position and, as shown inFIG. 9( b), the cam 30 also remains in neutral position (with the blackbutton also remaining in neutral position).

Referring now to FIG. 10, the handle is squeezed to advance the firstsuture 80 a (captured in the needle) ahead of the second suture 80 bresiding in slot 17. FIG. 10( a) shows the needle 55 being advanced,which positions the first suture 80 a ahead of the second suture 80 b.As shown in FIG. 10( b), the black button (the thumb pad 54) remains inthe neutral position while the cam 30 locks the handle in a forwardposition.

FIG. 11 illustrates the position of the various components of theinstrument as during passing of the first suture strand 80 a by fullysqueezing the handle. The cam will reset and allow the handle to fullyopen to let the needle retract and grab the second suture 80 b. Thesecond suture 80 b is then passed by fully squeezing the handle. Asshown in FIG. 11( a), the black button remains in the neutral position,while the cam compresses and allows the handle to fully release.

The suture passing instrument 100 of the present invention, describedabove with reference to FIGS. 1-13, may be employed in various surgicalmedical procedures for advancing the sutures in the proximity of asurgical site, and for employing the sutures with a cannulatedinstrument during such surgical procedures, such as arthroscopic rotatorcuff repair shown in FIG. 15. Additionally, the suture passinginstrument may be utilized in other general surgical and specialtyprocedures that require suturing at a remote site, such as inside thebody. The suture passing instrument of the present invention may be alsoused in repairs where suture visibility or finger access can be limited.

In an exemplary and illustrative embodiment only, a method of suturingtissue using the suture passing instrument 100 of the present inventioncomprises the steps of: (i) positioning a first flexible strand within ajaw of suture passing instrument 100; (ii) engaging the first flexiblestrand with a needle passing through the lower jaw of the instrument;(iii) positioning a second flexible strand within the jaw of the passinginstrument; (iv) advancing the needle with the first flexible strand;and (v) passing the first flexible strand through anatomical tissue tobe sutured.

According to another exemplary and illustrative embodiment only, amethod of suturing a tissue using the suture passing instrument 100 ofthe present invention comprises the steps of: (i) loading a first suturestrand onto a bottom jaw of a suture passing instrument; (ii) capturingthe first suture strand with a needle; (iii) loading a second suturestrand onto the bottom jaw of the suture passing instrument; (iv)closing the jaws on a desired, first region of the tissue using a fingerlever and advancing the needle (with the first suture strand engaged andcaptured thereon) through a first region of the tissue; (v) retractingthe needle; (vi) capturing the second suture strand with the needle andadvancing the needle (with the second suture strand engaged and capturedthereon) through a second region of the tissue; and (vii) retrieving thefirst and second sutures using a retriever or grasper.

Reference is now made to FIGS. 14( a)-(e) and 15 which illustrateexemplary suturing steps during an arthroscopic rotator cuff repair andemploying the suture passing instrument 100 of the present invention.Once suture passing instrument 100 has been loaded with needle 55 andflexible suture strands 80 a, 80 b, the upper jaw 10 a and the lower jaw10 b are brought together (in a closed position) and the suture passinginstrument 100 is advanced into the proximity of tissue 90 to besutured. The two jaws may be held together (in the closed position) byactuating the releaser 22 c (from an “Unlock” position to a “Lock”position). The upper jaw 10 a is then disengaged from the lower jaw 10 bby releasing the finger lever 22 a and a desired bite of tissue isgrasped (see FIGS. 14( a) and 14(b)).

With the jaws closed around the tissue (and preferably with the releaser22 c in the “Lock” position), the proximal and distal members 29 a, 29 bof the handle 28 of the handle assembly 20 are squeezed together so thatthe needle is advanced distally, exiting the opening 15 on the lower jaw10 b. Once the loaded instrument 100 is gently squeezed with the palm ofthe hand, the needle 55 advances and will pass the first loaded suture80 a first (see FIG. 14( c)). The needle is then retracted, and willengage and pass the second loaded suture 80 b. The passed sutures arethen retrieved (see FIGS. 14( d) and 14(e)).

While the suture passing instrument 100 may be particularly useful forperforming remote procedures through access sheaths, trocars andcannulated surgical instruments, it will also find use in open surgicalprocedures. In addition, although the suture passing instrument 100 ofthe present invention has been described above as being configured forloading two flexible strands, the suture passing instrument 100 may bealso employed with only one loaded flexible strand or with any pluralityof flexible strands.

While the present invention is described herein with reference toillustrative embodiments for particular applications, it should beunderstood that the invention is not limited thereto. Those havingordinary skill in the art and access to the teachings provided hereinwill recognize additional modifications, applications, embodiments andsubstitution of equivalents all fall within the scope of the invention.Accordingly, the invention is not to be considered as limited by theforegoing description.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. A method of passing suture through tissue, themethod comprising the steps of: providing a suture passing instrumentcomprising: a shaft having a distal end and a proximal end; a first jawprovided with an opening configured to receive a needle; a second jawmounted to the distal end of the shaft and pivotally connected to thefirst jaw such that the second jaw is moveable with respect to the firstjaw; and a handle assembly; loading a first suture strand into a slot inthe first jaw, with the needle in a first position; advancing the needleto a second position such that the first suture is shifted from the slotin the first jaw into a slot in the needle; retracting the needle to thefirst position; loading a second suture strand into the slot in thefirst jaw, so that the first suture strand is positioned offset from thesecond suture strand with respect to a most distal tip of the first jaw;closing the first and second jaws, and advancing the instrument in thevicinity of the tissue; actuating the first and second jaws to grasp thetissue; advancing the needle to pass the first suture strand through thetissue; retracting the needle to the second position such that thesecond suture is shifted from the slot in the first jaw into a slot inthe needle; and advancing the needle to pass the second suture strandthrough the tissue.
 2. The method of claim 1, wherein the first suturestrand is positioned laterally to the second suture strand with respectto a longitudinal axis of the shaft.
 3. The method of claim 1, whereinthe first suture strand is positioned distally to the second suturestrand relative to the handle assembly.
 4. The method of claim 1,further comprising the step of: initially sliding the needle through acannulation in a proximal end of the shaft such that a distal end of theneedle is on the distal end of the shaft.
 5. A method of suturing tissueat a surgical site, comprising: providing a suture passing instrumentcomprising: a shaft having a distal end and a proximal end; a lower jawintegral to the distal end of the shaft and configured to receive aneedle, the lower jaw being provided with a groove to secure at leastone flexible strand thereon; an upper jaw mounted to the distal end ofthe shaft and pivotally connected to the lower jaw such that the upperjaw is moveable with respect to the lower jaw member; and a handleassembly comprising a handle, a ratchet-like mechanism including afinger lever with a ratchet and a releaser with a hook, and a cammechanism; mounting the needle in the suture passing instrument bysliding the needle through a cannulation in the proximal end of theshaft such that a distal end of the needle is on the distal end of theshaft; loading a first flexible strand into the groove of the lower jaw;transferring the first flexible strand from the groove of the lower jawinto a slot in the needle; loading a second flexible strand into thegroove of the lower jaw, so that the second flexible strand is locateddistally to the first flexible strand with respect to a most distal endof the lower jaw; and closing the lower and upper jaws and advancing thesuture passing instrument in the vicinity of tissue to be sutured. 6.The method of claim 5 further comprising the step of sequentially andindependently passing the first and second flexible strands throughtissue.
 7. The method of claim 5, wherein the step of loading the secondflexible strand into the groove of the lower jaw is conducted withoutremoving the instrument out of the surgical site.
 8. The method of claim5, further comprising the steps of: opening the upper jaw by moving thefinger lever subsequent to disengaging the ratchet and the hook, andgrasping a desired bit of tissue using the upper and lower jaws; closingthe upper and lower jaws by using the finger lever; capturing the firstflexible strand with the needle; advancing the first flexible strandthrough the tissue; retracting the needle; capturing the second flexiblestrand with the needle; advancing the second flexible strand through thetissue; and retracting the needle.
 9. The method of claim 8, wherein thesteps of advancing the first and second flexible strands through tissuefurther comprises advancing the needle by pushing proximal and distalmembers of the handle toward each other until the needle exits theopening on the lower jaw and advances toward the upper jaw.
 10. Themethod of claim 5, wherein at least one of the first and second flexiblestrands is a suture comprising a plurality of high strength fibers. 11.The method of claim 5, wherein the surgical site is a rotator cuff. 12.The method of claim 5, wherein the needle is a bendable needle.
 13. Themethod of claim 5, wherein the needle is a nitinol needle.